The efficacy and safety of 'CGGEL' for bleeding during endoscopic papillectomy or endoscopic sphincterotom: randomized, controlled trial
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0005607
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Background: Endoscopists often experience obstacles with traditional hemostasis using the side-viewing duodenoscope for bleeding after endoscopic sphincterotomy (EST) or endoscopic papillectomy (EP). Aims: In this randomized controlled trial, we evaluated the efficacy and safety of a novel hemostatic gel for post-EST or post-EP bleeding. Methods: A randomized trial was conducted from November 2020 to December 2021 at two tertiary centers in South Korea. Patients who experienced bleeding immediately after EST or EP were enrolled in the study, and primary hemostasis was achieved with either the novel hemostatic gel or epinephrine spray. Results: A total of 84 patients were enrolled in this study, and 41 patients were finally analyzed in each group. Hemostatic gel was significantly superior to epinephrine spray for successful primary hemostasis (100% vs. 85.4%; P = 0.026). ). In terms of delayed bleeding, no significant difference was observed between the hemostatic gel and epinephrine spray (2.4% vs. 7.3%; P = 0.329). The mean procedural time was significantly higher for the hemostatic gel than epinephrine spray (3.23 ± 1.94 vs. 1.76 ± 0.99 min; P < 0.001), and no differences were observed in the adverse events. Conclusions: The novel hemostatic gel is expected to achieve satisfactory results with easier hemostasis for immediate bleeding after EST or EP. (Registered in Clinical Research Information Service: KCT0005607). Keywords: Endoscopic papillectomy; Endoscopic sphincterotomy; Hemostatic gel; Post-procedural bleeding; Randomized controlled trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 84
1. Adult over 19 years old
2. A person who shows endoscopic bleeding or is expected to bleed during an endoscopic sphincterotomy or endoscopic papillectomy for the treatment of pancreatic or biliary tract disease*
* pancreatobiliary diseases: AoV adenoma, bile duct stone, cholangitis, cholecystitis, sphincter of Oddi dysfunction, choledochal cyst, benign and malignant biliary strictures, acute/chronic pancreatitis, bile leakage, primary sclerosing cholangitis, primary biliary cholangitis
3. A person who is able to comply with the clinical trial requirements
4. A person who is able to give written informed consent prior to the clinical trial start
1. Coagulopathy or Hemostatic disorder (platelet <50,000/µl, INR> 1.5)
2. Active organ failure
3. Those who cannot stop taking antiplatelet drugs or anticoagulants
4. Those who have received/received other investigational drugs or medical devices within 4 weeks of screening
5. Pregnant or breast-feeding women
6. Those who have hypersensitivity to investigational medical devices or components
7. Those who are considered not suitable for the clinical trial by investigator
8. Those with active gastrointestinal bleeding or difficulty accessing the Ampulla of Vater through an endoscope
9. Those who did not have endoscopic bleeding on the day of endoscopic procedure
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hemostasis rate for immediate bleeding
- Secondary Outcome Measures
Name Time Method hemostasis rate for delayed bleeding